[ EU MDR 深入探討: CER, PMCF 和 PMS 為何物? (上) ]

" US FDA與EU Medical Device Regulation (MDR) 對於Class II醫療器材管控上有個明顯的差異點，那就是對於臨床的管控方式！當走US FDA 510(k)途徑時，只要實質比對的predicate device並無進行人體臨床，而自家的產品與predicate device有相同的適應症和技術特徵之情況下，有很高機率不會被FDA要求執行臨床試驗；但是EU's MDR 對於Class IIa & IIb 醫材於上市前會要求執行Clinical Evaluation，而且上市後Notified Body會持續透過PMS與PMCF來監控廠商之產品於臨床上的情況．因此透過分析CER/ PMCF/ PMS，讓我們一窺US FDA和EU對於醫材管控的差異．"

前情提要：在上一篇 [ EU Medical Device Regulation (MDR) 的基本須知 ] 中提及了新版MDR將帶來哪些改變，本篇即是繼續深入探討MDR如何要求廠商持續性的收集與監控臨床數據！

在產品設計開發階段就須藉由Risk Management與Clinical Evaluation來分析自家產品的潛在風險以及需達到的臨床功效指標，並透過bench tests or animal study or clinical trial來證實產品能達到預期的安全性與功效性宣稱，以通過EU Notified Body的上市前技術審查，但是並非取得上市許可就結束了，EU在意的是整個產品生命週期的管控，因此，於上市前需透過Clinical Evaluation分析產品有哪些Residual Risks需長期臨床追蹤，並寫進Post-Market Clinical Follow-up (PMCF) Plan中，所以上市前Clinical Evaluation Report (CER)與PMCF Plan會是Notified Body審查的重點之一；

上市後Notified Body會依據廠商所提供的Post-Market Surveillance (PMS) Plan與PMCF Plan，定期追蹤廠商執行的情況，要留意的是，當PMS和PMCF有任何情況，記得要定期回去update CER與Risk Management，並分析是否有新的Residual Risks產生！

呼~ 這是個龐大的討論議題，為了避免一次塞太多東西過於雜亂，於是我將文章分成上下回，本篇(上回)先分析CER/ PMCF/ PMS這三者的關聯性；下回即會進一步探討CER/ PMCF/ PMS這三者的執行重點．


引用資料：
- BSI - What are the requirements for vigilance reporting and post-market surveillance?
- “ MDDSN | 醫循 — 提供醫療器材商品化一條可依循的開發取證途徑！ ”

- MEDDEV 2.12/2 rev2 - POST MARKET CLINICAL FOLLOW-UP STUDIES

名詞定義：

1. Clinical Evaluation: The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
2. Residual Risk: Risk remaining after risk control measures has been taken.
3. Post-market clinical follow-up (PMCF): Clinical investigation conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking.
4. Post-market clinical follow-up (PMCF) study: A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling.
5. Post-market surveillance (PMS): All activities carried out by the manufacturer, in cooperation with other economic operators, to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.